D. Lu

发表

A survey of new oncology drug approvals in the USA from 2010 to 2015: a focus on optimal dose and related postmarketing activities

Dan Lu, Amita Joshi, Tong Lu, 2016, Cancer Chemotherapy and Pharmacology.

Physiologically Based Pharmacokinetic Modeling as a Tool to Predict Drug Interactions for Antibody-Drug Conjugates

Jin Y. Jin, Yuan Chen, S. Girish, 2014, Clinical Pharmacokinetics.

Preclinical pharmacokinetics of MEHD7945A, a novel EGFR/HER3 dual-action antibody, and prediction of its human pharmacokinetics and efficacious clinical dose

M. Sliwkowski, G. Schaefer, A. Kamath, 2012, Cancer Chemotherapy and Pharmacology.

Platform model describing pharmacokinetic properties of vc-MMAE antibody–drug conjugates

Jin Y. Jin, L. Gibiansky, S. Girish, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

Integrated Two‐Analyte Population Pharmacokinetic Model for Antibody–Drug Conjugates in Patients: Implications for Reducing Pharmacokinetic Sampling

L. Gibiansky, S. Girish, A. Joshi, 2016, CPT: pharmacometrics & systems pharmacology.

Pharmacokinetic and Pharmacodynamic‐Based Drug Interactions for Therapeutic Proteins

F. Theil, S. Girish, A. Joshi, 2013 .

Semi-mechanistic Multiple-Analyte Pharmacokinetic Model for an Antibody-Drug-Conjugate in Cynomolgus Monkeys

Jin Y. Jin, S. Ramanujan, S. Girish, 2014, Pharmaceutical Research.

Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study.

Manish R. Patel, R. Advani, A. Hagenbeek, 2015, The Lancet. Oncology.

Clinical pharmacology of vc-MMAE antibody–drug conjugates in cancer patients: learning from eight first-in-human Phase 1 studies

S. Girish, Shang-Chiung Chen, B. Fine, 2019, mAbs.

The effect of Bruton's tyrosine kinase (BTK) inhibitors on collagen‐induced platelet aggregation, BTK, and tyrosine kinase expressed in hepatocellular carcinoma (TEC)

T. Kinoshita, M. Versele, J. Sukbuntherng, 2018, European journal of haematology.

Phase I Study of the Anti-CD22 Antibody–Drug Conjugate Pinatuzumab Vedotin with/without Rituximab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

R. Advani, B. Cheson, A. Goy, 2016, Clinical Cancer Research.

Antibody delivery of drugs and radionuclides: factors influencing clinical pharmacology.

F. Theil, L. Khawli, S. Prabhu, 2011, Therapeutic delivery.

Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS).

A. Hagenbeek, G. Salles, L. Sehn, 2019, The Lancet. Haematology.

Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study.

G. Salles, K. Kolibaba, H. Tilly, 2019, The Lancet. Oncology.

Final Results of a Phase I Study of the Anti-CD79b Antibody-Drug Conjugate DCDS4501A (Polatuzumab Vedotin) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma 4400

R. Advani, G. Salles, M. Czuczman, 2013 .

Time‐to‐Event Modeling of Peripheral Neuropathy: Platform Analysis of Eight Valine‐Citrulline‐Monomethylauristatin E Antibody–Drug Conjugates

Jin Y. Jin, S. Girish, B. Fine, 2019, CPT: pharmacometrics & systems pharmacology.

Integrated Two‐Analyte Population Pharmacokinetic Model of Polatuzumab Vedotin in Patients With Non‐Hodgkin Lymphoma

Jin Y. Jin, L. Gibiansky, S. Girish, 2019, CPT: pharmacometrics & systems pharmacology.

Time‐to‐Event Analysis of Polatuzumab Vedotin‐Induced Peripheral Neuropathy to Assist in the Comparison of Clinical Dosing Regimens

S. Girish, M. Kågedal, D. Lu, 2017, CPT: pharmacometrics & systems pharmacology.

Impact of Physiologically Based Pharmacokinetics, Population Pharmacokinetics and Pharmacokinetics/Pharmacodynamics in the Development of Antibody‐Drug Conjugates

Jin Y. Jin, Yuan Chen, S. Girish, 2020, Journal of clinical pharmacology.

Pharmacokinetics of polatuzumab vedotin in combination with R/G-CHP in patients with B-cell non-Hodgkin lymphoma

Jin Y. Jin, S. Girish, D. Lu, 2020, Cancer Chemotherapy and Pharmacology.

Pharmacokinetics of trastuzumab emtansine (T-DM1) as a single agent or in combination with pertuzumab in HER2-positive breast cancer patients with recurrent or locally advanced metastatic breast cancer

Jin Y. Jin, S. Girish, Shang-Chiung Chen, 2019, Cancer Chemotherapy and Pharmacology.

Pharmacokinetics, Bioequivalence, and Safety Studies of a Generic Selective Tyrosine Kinase Inhibitor Nilotinib Capsule Versus a Branded Product in Healthy Chinese Volunteers

Hao Wang, Hao Wang, D. Lu, 2022, Clinical pharmacology in drug development.

Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma

L. Gibiansky, S. Girish, Rong Shi, 2020, Cancer Chemotherapy and Pharmacology.

Final Results Of a Phase I Study Of The Anti-CD79b Antibody-Drug Conjugate DCDS4501A In Relapsed Or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (NHL)

R. Advani, G. Salles, L. Sehn, 2013 .

An in vitro quantitative systems pharmacology approach for deconvolving mechanisms of drug-induced, multilineage cytopenias

James Lu, Jennifer L. Wilson, Aaron M Fullerton, 2019, bioRxiv.

Model-Based Meta-Analysis for Quantifying Paclitaxel Dose Response in Cancer Patients

H. Li, A. Joshi, D. Lu, 2014, CPT: pharmacometrics & systems pharmacology.

Preclinical pharmacokinetics of MFGR1877A, a human monoclonal antibody to FGFR3, and prediction of its efficacious clinical dose for the treatment of t(4;14)-positive multiple myeloma

A. Kamath, J. Qing, J. Stephan, 2012, Cancer Chemotherapy and Pharmacology.

A Guide to Rational Dosing of Monoclonal Antibodies

D. Allison, A. Joshi, Y. Xin, 2012, Clinical Pharmacokinetics.

Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody–drug conjugate in development for the treatment of HER2-positive cancer

Dan Lu, Amita Joshi, Patricia M. LoRusso, 2012, Cancer Chemotherapy and Pharmacology.

Ethnic sensitivity assessment of the antibody–drug conjugate trastuzumab emtansine (T-DM1) in patients with HER2-positive locally advanced or metastatic breast cancer

S. Girish, Michael W. Lu, I. Nijem, 2016, Cancer Chemotherapy and Pharmacology.

Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer

P. LoRusso, M. Pegram, A. Elias, 2016, Breast Cancer Research.

Population pharmacokinetics of trastuzumab emtansine (T-DM1), a HER2-targeted antibody–drug conjugate, in patients with HER2-positive metastatic breast cancer: clinical implications of the effect of covariates

M. Cobleigh, S. Girish, P. Conte, 2014, Cancer Chemotherapy and Pharmacology.

An Integrated Multiple-Analyte Pharmacokinetic Model to Characterize Trastuzumab Emtansine (T-DM1) Clearance Pathways and to Evaluate Reduced Pharmacokinetic Sampling in Patients with HER2-Positive Metastatic Breast Cancer

H. Burris, S. Girish, I. Krop, 2013, Clinical Pharmacokinetics.

Exposure–response analysis of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia: pooled results from a phase 1b study and the phase 3 MURANO study

L. Gibiansky, A. Kater, S. Girish, 2020, Leukemia & lymphoma.

Prediction of Human Pharmacokinetics of Antibody–Drug Conjugates From Nonclinical Data

S. Girish, A. Kamath, S. Prabhu, 2019, Clinical and translational science.

Assessment of Correlation Between Early and Late Efficacy Endpoints to Identify Potential Surrogacy Relationships in Non-Hodgkin Lymphoma: a Literature-Based Meta-analysis of 108 Phase II and Phase III Studies

Michelle L. Green, D. Lu, R. Zhu, 2017, The AAPS Journal.

Preliminary results of a phase II randomized study (ROMULUS) of polatuzumab vedotin (PoV) or pinatuzumab vedotin (PiV) plus rituximab (RTX) in patients (Pts) with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).

R. Advani, A. Hagenbeek, G. Salles, 2014 .

Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study

L. Gibiansky, A. Kater, S. Girish, 2019, Clinical Pharmacokinetics.

Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates?

Stephanie N. Liu, M. Kågedal, D. Lu, 2021, Clinical pharmacology and therapeutics.

Application of a Two-Analyte Integrated Population Pharmacokinetic Model to Evaluate the Impact of Intrinsic and Extrinsic Factors on the Pharmacokinetics of Polatuzumab Vedotin in Patients with Non-Hodgkin Lymphoma

L. Gibiansky, S. Girish, Rong Shi, 2020, Pharmaceutical Research.

Strategies to address drug interaction potential for antibody-drug conjugates in clinical development.

S. Girish, S. Sahasranaman, D. Lu, 2013, Bioanalysis.

Applying interpretable machine learning workflow to evaluate exposure–response relationships for large‐molecule oncology drugs

James Lu, Gengbo Liu, D. Lu, 2022, CPT: pharmacometrics & systems pharmacology.

Performance of Cox proportional hazard models on recovering the ground truth of confounded exposure–response relationships for large‐molecule oncology drugs

D. Lu, Victor Poon, 2022, CPT: pharmacometrics & systems pharmacology.

Updated Results of a Phase II Randomized Study (ROMULUS) of Polatuzumab Vedotin or Pinatuzumab Vedotin Plus Rituximab in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma

R. Advani, A. Hagenbeek, G. Salles, 2014 .

Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma

L. Gibiansky, S. Girish, Rong Shi, 2020, Leukemia & lymphoma.

A Phase I Study of DCDT2980S, an Antibody-Drug Conjugate (ADC) Targeting CD22, in Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

R. Advani, B. Cheson, Zheng Su, 2012 .

Exposure-Response Analysis to Assist Selection of Dose and Treatment Duration for Polatuzumab Vedotin As a Single Agent or in Combination with Rituximab for the Treatment of B-Cell Lymphoma

L. Gibiansky, S. Girish, D. Lu, 2015 .

A Phase I Study of the Safety and Pharmacokinetics of Escalating Doses of MFGR1877S, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody, in Patients with Relapsed or Refractory t(4;14)-Positive Multiple Myeloma

P. L. Bergsagel, S. Trudel, S. Singhal, 2012 .

Integrated summary of immunogenicity of polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma

R. L. Beardsley, D. Lu, Randall C Dere, 2023, Frontiers in Immunology.

Semi-mechanistic Multiple-Analyte Pharmacokinetic Model for an Antibody-Drug-Conjugate in Cynomolgus Monkeys

S. Ramanujan, S. Girish, S. Prabhu, 2014, Pharmaceutical Research.

Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer.

H. Burris, S. Girish, J. Cortés, 2012, Current drug metabolism.

Final Results Of a Phase I Study Of The Anti-CD22 Antibody-Drug Conjugate (ADC) DCDT2980S With Or Without Rituximab (RTX) In Patients (Pts) With Relapsed Or Refractory (R/R) B-Cell Non-Hodgkin’s Lymphoma (NHL)

B. Cheson, A. Goy, E. Hochberg, 2013 .

Pharm‐AutoML: An open‐source, end‐to‐end automated machine learning package for clinical outcome prediction

James Lu, Gengbo Liu, D. Lu, 2021, CPT: pharmacometrics & systems pharmacology.

Exposure–response analyses of trastuzumab emtansine in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane

S. Girish, Shang-Chiung Chen, A. Joshi, 2017, Cancer Chemotherapy and Pharmacology.

P1-12-07: Pharmacokinetics (PK) of Trastuzumab Emtansine and Paclitaxel or Docetaxel in Patients with HER2−Positive MBC Previously Treated with a Trastuzumab-Containing Regimen.

S. Girish, A. Elias, S. Modi, 2011 .

Exposure–efficacy relationship of trastuzumab emtansine (T-DM1) in EMILIA, a phase III study of T-DM1 versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC).

S. Swain, M. Untch, S. Girish, 2013 .

Platform model describing pharmacokinetic properties of vc-MMAE antibody–drug conjugates

L. Gibiansky, S. Girish, Shang-Chiung Chen, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

D. Lu, A. Chai, Y. Chu, 2017, The AAPS Journal.